roche delivers strong performance in the first half of 201590ee0418-8b9d-4ad3-b... · 2/26...

Investor Update

F. Hoffmann-La Roche Ltd 4070 Basel Switzerland

Investor Relations email: [email protected]

Tel. +41 61 68-88880 Fax +41 61 69-10014 www.roche.com

Basel, 28 January 2016

Roche reports strong results in 2015

x Group sales increased by 5%1 at constant exchange rates, 1% in Swiss francs x Pharmaceuticals Division sales up 5%, driven by oncology medicines Herceptin, Avastin and

Perjeta as well as Esbriet for idiopathic pulmonary fibrosis x Diagnostics Division sales grew by 6%, driven primarily by immunodiagnostic products x Major pipeline progress: ocrelizumab with positive phase III data for relapsing and for

primary progressive forms of multiple sclerosis; and promising results for atezolizumab in bladder and lung cancer

x Fully automated cobas 6800 and cobas 8800 systems launched in the US in Molecular Diagnostics

x Core earnings per share2 up 7% at constant exchange rates excluding the sale of filgrastim rights in 2014, -3% in Swiss francs

x Board proposes dividend increase to CHF 8.10 x Outlook for 2016: sales expected to grow low- to mid-single digit, at constant exchange rates.

Core earnings per share targeted to grow ahead of sales at constant exchange rates. Roche expects to further increase its dividend in Swiss francs

Key figures 2015 CHF millions % change

2015 2014 CER1 CHF

Group sales 48,145 47,462 +5 +1Pharmaceuticals Division 37,331 36,696 +5 +2Diagnostics Division 10,814 10,766 +6 0

Core operating profit 17,542 17,636 +5 -1excluding filgrastim2 +7 +2

Core EPS - diluted (CHF) 13.49 14.29 +4 -6excluding filgrastim2 +7 -3

IFRS net income 9,056 9,535 +4 -5

1 Unless otherwise stated, all growth rates in this document are at constant exchange rates (CER: average 2014). 2 Excluding the one-time benefit of CHF 428 million before tax related to the divestment of filgrastim rights in 2014.

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Commenting on the Group’s results, Roche CEO Severin Schwan said: “2015 was a successful year, with

strong business results in both Pharmaceuticals and Diagnostics, driven by our newly launched medicines

and diagnostic platforms. I am particularly pleased with the progress of our product pipeline. We reported

important clinical data across several areas including cancer, multiple sclerosis, immune and blood diseases.

Based on our strong product portfolio and promising pipeline, we are well positioned for the future.”

Group Strong sales growth in both Divisions

In 2015, Group sales increased by 5% to CHF 48.1 billion, driven primarily by pharmaceutical sales in the US

and by strong demand for immunodiagnostic products.

In the Pharmaceuticals Division, sales rose 5% to CHF 37.3 billion. The increase was driven by the oncology

portfolio (+8%), led by the HER2 medicines and Avastin. Sales of the immunology franchise grew by 24%,

driven by the strong uptake of Esbriet, a new medicine for idiopathic pulmonary fibrosis, as well as higher

sales of Actemra/RoActemra and Xolair. Sales of Pegasys declined due to competition from a new generation

of treatments, while Valcyte/Cymevene and Xeloda faced generic competition as expected.

All regions contributed to the sales growth, with particularly strong performance in the US (+6%) and in

Europe (+4%), which was driven by strong demand for the HER2 medicines along with strong uptake of

Esbriet. Growth in the International region3 (+5%) was driven by key markets including Brazil (+10%) and

China (+4%). In Japan, sales grew by 6%, driven by Avastin, the HER2 franchise and the new lung cancer

medicine Alecensa.

In Diagnostics, sales grew 6% to CHF 10.8 billion, with Asia-Pacific (+15%) and Europe, Middle East and

Africa (EMEA, +4%) as the main contributors. Sales were up in Latin America (+11%) and in North America

(+3%), whilst sales in Japan were stable. The major growth driver was Professional Diagnostics, which grew

by 8%. Sales in Molecular Diagnostics and Tissue Diagnostics increased 10% and 12% respectively. Diabetes

Care sales decreased 3% due to continuing challenging market conditions, especially in the US.

Profitability growth ahead of sales

Excluding a one-time income of CHF 428 million from the sale of filgrastim rights in 2014, core operating

profit increased 7% at constant exchange rates. On the same basis, core earnings per share (CHF 13.49) were

7% higher.

3 Asia-Pacific, EEMEA (Eastern Europe, Middle East, Africa), Latin America, Canada, Others.

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IFRS net income increased 4% at constant exchange rates, but declined 5% in Swiss franc terms due to a

major negative currency impact.

The Board of Directors has recommended a dividend increase to CHF 8.10 per share and non-voting equity

security. Subject to approval by the Annual General Meeting of shareholders on 1 March 2016, this will be

Roche’s 29th consecutive annual dividend increase.

Product approvals and portfolio progress

Roche made significant progress with launches of new medicines and diagnostics as well as its product

pipeline. In 2015, Roche obtained five major approvals and four FDA breakthrough therapy designations on

its medicines.

In the past year, Roche presented important results from a number of key clinical trials. For ocrelizumab,

Roche announced positive phase III data in relapsing forms of MS and in primary progressive MS (PPMS).

Ocrelizumab is the first medicine to show a clinically meaningful impact on the progression of disability in

people with PPMS in a pivotal phase III trial. Roche will submit the data in relapsing forms of MS and PPMS

to global health authorities in 2016.

In January 2016, Roche completed the US filing for its lead investigational cancer immunotherapy medicine

atezolizumab in metastatic bladder cancer and expects to complete a second filing in metastatic lung cancer

soon. Late in 2015, Roche received approvals in the US and EU for Cotellic in combination with Zelboraf to

treat metastatic melanoma. In December, the US FDA granted accelerated approval for Roche’s cancer

medicine Alecensa in a specific form of non-small cell lung cancer.

In Diagnostics, Roche further extended its industry-leading product portfolio with seven test and eight

instrument launches, including new cobas 6800 and cobas 8800 systems in Molecular Diagnostics and the

Ventana HE 600 system in Tissue Diagnostics.

Strategic partnerships to improve patient care

In January 2016, Roche announced a partnership with Flatiron Health, an industry leader in real-world

oncology data. Building on the collaboration with Foundation Medicine, begun in 2015, this agreement is

another important milestone to drive our leadership in personalised healthcare. High-quality healthcare data

and advanced analytics will improve both the development of medicines and the quality of treatment

decisions. In 2015, Roche also acquired Ariosa Diagnostics, Signature Diagnostics, CAPP Medical and Kapa

Biosystems, companies with strong expertise and technologies which will complement Roche’s activities

aimed at building a next-generation sequencing portfolio.

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Outlook for 2016

In 2016, Roche expects sales to grow low- to mid-single digit, at constant exchange rates. Core earnings per

share are targeted to grow ahead of sales at constant exchange rates. Roche expects to further increase its

dividend in Swiss francs.

Pharmaceuticals Division

Key figures 2015 CHF millions As % of sales % change

2015 2014 2015 2014 CER CHF

Pharmaceuticals Division 37,331 36,696 100 100 +5 +2 United States 17,616 15,822 47 43 +6 +11 Europe 8,734 9,422 23 26 +4 -7 Japan 3,224 3,301 9 9 +6 -2 International* 7,757 8,151 21 22 +5 -5

*Asia-Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, Others.

Key pharmaceutical products in 2015

Herceptin, Perjeta and Kadcyla (combined +19%), for HER2-positive breast cancer and HER2-positive

metastatic gastric cancer (Herceptin only), were strong growth drivers in 2015. Herceptin again recorded

strong sales growth (+10%), especially in the US (+15%), with longer duration of treatment in combination

with Perjeta for both early and advanced breast cancer. Strong demand was also seen in the International

region (+16%), notably in China and Brazil. Perjeta (+61%) also performed well, particularly in the US and

Europe, where it was approved for use before surgery in early-stage aggressive breast cancer. There was also

good growth in Japan. Kadcyla sales (+51%) were driven primarily by demand in Europe, with

reimbursement granted in Italy, France and Spain.

MabThera/Rituxan (+5%), for common forms of blood cancers, including non-Hodgkin lymphoma (NHL),

follicular lymphoma and chronic lymphocytic leukemia (CLL), and for rheumatoid arthritis and certain types

of vasculitis, performed well. Sales growth was driven primarily by strong demand in the US (+7%), as

demand continued to increase in oncology and immunology. Sales grew 4% in the International region, led

by increasing demand in Brazil and China, and 11% in Japan.

Avastin (+9%), for advanced colorectal, breast, lung, kidney, cervical and ovarian cancer and glioblastoma (a

type of brain tumour), posted strong sales growth. Increased sales were seen across all regions due to rising

demand in ovarian, colorectal, lung and cervical cancer, following launches in Europe and emerging markets.

Strong growth was seen in the US (+8%) and the International region (+15%), particularly in China where

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uptake for colorectal cancer and the new lung cancer indication fuelled growth. In Japan (+14%), growth was

driven by demand in breast and lung cancer.

Lucentis (-15%, US only), for eye conditions, wet age-related macular degeneration (wAMD), macular

edema following retinal vein occlusion (RVO) and diabetic macular edema (DME), was impacted by

competitive pressure in the wAMD and DME segments. In February 2015, the FDA approved Lucentis for an

additional indication, diabetic retinopathy in people with DME.

Actemra/RoActemra (+23%), for rheumatoid arthritis, systemic juvenile idiopathic arthritis and

polyarticular juvenile idiopathic arthritis, recorded strong growth. Sales increased across all regions, driven

by strong demand for the subcutaneous formulation, particularly in the US (+29%) and Europe (+22%). In

June 2015, the FDA granted breakthrough therapy designation for Actemra in systemic sclerosis.

Esbriet (CHF 563 million), for idiopathic pulmonary fibrosis (IPF), a fatal lung disease, had continued strong

uptake. Approved by the FDA and Swissmedic in 2014, sales reached CHF 386 million in the US, CHF 152

million in Europe and CHF 25 million in the International region. In September 2015, additional data were

presented from a pooled analysis of three phase III studies that suggested a reduction in treatment-emergent

risk of death for IPF patients taking Esbriet for up to two years.4

Zelboraf (-21%), for BRAF V600 mutation-positive advanced melanoma, has been under intense competitive

pressure as the standard of care moves from monotherapy to targeted combinations. In November 2015, the

US and EU authorities approved Roche’s combination of Zelboraf plus Cotellic for the treatment of this type

of melanoma. In addition, updated clinical trial results showed that the combination helped people with

BRAF-mutated advanced melanoma live significantly longer than Zelboraf alone.

Gazyva/Gazyvaro (CHF 128 million), for the treatment of CLL, had good sales growth. Despite competitive

pressure, there was good uptake in the US and other early-launch countries. Further growth is expected as

additional markets secure reimbursement. A pivotal study showed that Gazyva/Gazyvaro provided

substantial benefit in people with indolent non-Hodgkin lymphoma who did not achieve adequate disease

control from a previous MabThera/Rituxan based regimen. These data have been submitted to health

authorities for approval consideration, and were accepted by the FDA for priority review.

4 Nathan SJ et al. Effect of Pirfenidone on Treatment-emergent (TE) All-cause Mortality (ACM) in Patients with Idiopathic Pulmonary Fibrosis (IPF): Pooled Data Analysis from ASCEND and CAPACITY. Abstract presented at ERS 2015.

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Top-selling Total sales United States Europe Japan International*

pharmaceuticals CHF m % CHF m % CHF m % CHF m % CHF m %

MabThera/Rituxan 7,045 5 3,760 7 1,818 1 230 11 1,237 4

Avastin 6,684 9 3,058 8 1,813 4 746 14 1,067 15

Herceptin 6,538 10 2,384 15 2,010 1 260 5 1,884 16

Lucentis 1,520 -15 1,520 -15 - - - - - -

Perjeta 1,445 61 804 41 432 102 84 16 125 140

Actemra/RoActemra 1,432 23 550 29 473 22 221 12 188 25

Xolair 1,277 25 1,277 25 - - - - - -

Tarceva 1,181 -7 638 -5 220 -18 92 1 231 -3

Activase/TNKase 935 20 890 21 - - - - 45 1

CellCept 785 0 201 -2 178 -8 56 7 350 4 * Asia-Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, Others.

Pipeline highlights

In 2015, Roche obtained five major marketing approvals, four FDA breakthrough therapy designations

(BTD) on its medicines, and positive results from key clinical trials of investigational medicines in

hematology, cancer immunotherapy and multiple sclerosis (MS). In the next three years, Roche expects

launches for up to eight new medicines.

Among key read-outs achieved in 2015, Roche announced very promising data for the treatment of MS.

Three positive late-stage clinical studies of ocrelizumab confirmed the hypothesis that B cells are central to

the pathogenesis of the disease. Ocrelizumab is the first investigational medicine to show positive results in

both primary progressive and relapsing forms of multiple sclerosis. We will submit these data to regulatory

authorities for marketing approval in 2016.

In 2016, Roche has either submitted or plans to file marketing applications for its lead investigational cancer

immunotherapy medicine atezolizumab in specific types of bladder and lung cancers to global health

authorities. In January 2016, Roche completed the filing of atezolizumab for people with metastatic urothelial

bladder cancer under the US FDA’s breakthrough therapy designation. Roche expects to complete a second

FDA filing of atezolizumab soon, under a separate BTD, for non-small cell lung cancer. In addition, Roche

presented encouraging early data from clinical trials of this promising investigational medicine in certain

types of advanced breast cancer and melanoma at international medical conferences in 2015.

In September 2015, the FDA granted breakthrough therapy designation for emicizumab (ACE910) for the

prophylactic treatment of people 12 years or older with hemophilia A. In December 2015, Roche presented

follow-up phase III data (GADOLIN study) on Gazyva/Gazyvaro, which showed that this medicine could

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further improve outcomes for patients with difficult-to-treat indolent non-Hodgkin lymphoma. In the same

month, a pivotal phase II study showed nearly 80% of people with hard-to-treat type of chronic lymphocytic

leukemia (CLL) responded to venetoclax, an investigational medicine being developed in partnership with

AbbVie. The FDA has just granted priority review for a marketing application for venetoclax as monotherapy

in previously treated CLL, as well as BTD for venetoclax in combination with MabThera/Rituxan in relapsed

or refractory CLL.

In the last quarter of 2015, Roche received marketing approvals in the US and EU for Cotellic in combination

with Zelboraf to treat a specific form of advanced melanoma. In December 2015, the US FDA granted

accelerated approval for Alecensa as a new option for people with ALK-positive NSCLC. A regulatory

decision in the EU is expected in 2016. Roche also received EU marketing approvals for Avastin for the

treatment of advanced cervical cancer and Perjeta combined with Herceptin and chemotherapy for the pre-

surgical treatment of early HER2-positive breast cancer.

Diagnostics Division

Diagnostics Division CHF millions

% change As % of sales Sales 2015 CER CHF

Sales – Diagnostics Division 10,814 +6 0 100

Business areas

Professional Diagnostics 6,175 +8 +2 57

Diabetes Care 2,128 -3 -11 20

Molecular Diagnostics 1,719 +10 +7 16

Tissue Diagnostics 792 +12 +11 7

Regions

Europe, Middle East, Africa 4,546 +4 -7 42

North America 2,856 +3 +7 26

Asia-Pacific 2,239 +15 +14 21

Latin America 760 +11 -5 7

Japan 413 0 -8 4

Strong growth driven by Professional Diagnostics Professional Diagnostics (+8%) was the major contributor to the Division’s performance in all regions, led by

Asia-Pacific with strong growth in China. Growth was primarily driven by the immunodiagnostics business

(+13%), which now represents 28% of divisional sales and contributes more than half to the Diagnostics

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growth. The sales of the clinical chemistry (+3%) and coagulation monitoring (+6%) businesses also

contributed to the Professional Diagnostics growth.

In Molecular Diagnostics, sales increased by 10%, driven by the regions EMEA (+14%) and North America

(+11%). The major growth contributors were the underlying molecular (+7%) and the sequencing businesses.

The underlying molecular business growth was driven by virology (+14%) including HPV screening (+27%).

This was supported by a number of tender contracts won in 2015, including the first national HPV primary

screening tender in the Netherlands. Major blood screening tender contracts were won in Thailand,

Germany, the UK and Spain with Roche’s next-generation cobas 6800 and cobas 8800 systems. Significant

competitive tenders in virology were awarded to Roche in the UK, France and Germany, with tests that will

also run on the new cobas systems.

Tissue Diagnostics increased sales by 12%, driven by the regions North America (+9%) and EMEA (+12%).

Sales in Asia-Pacific grew by 22%, with China being the main growth contributor. The growth in the

advanced staining portfolio (+11%) drove performance in Tissue Diagnostics. Revenues from external

partnerships showed continued strong growth.

In Diabetes Care, sales declined 3%, mainly due to a spillover of Medicare prices to commercial plans for the

blood glucose monitoring portfolio in the US. Sales decreased in North America, EMEA and Japan, but grew

in Latin America and Asia-Pacific. Sales increased for Accu-Chek Mobile (+8%), lancing devices (+5%) and

insulin delivery systems (IDS, +8%). Growth in the IDS business was driven by infusion systems and the

newly launched Accu-Chek Insight system. Overall, business efficiencies were gained with streamlined

processes and cost reductions.

Automation and connectivity in laboratory practice

Newly launched instruments offer increased testing capacity, highest levels of automation, more connected

workflows and laboratory information systems. Greater automation and connectivity helps to support

laboratories in increasing their operational efficiencies.

A key milestone in 2015 was the FDA approval of the cobas 6800 and cobas 8800 systems and the cobas

HBV, cobas HCV and cobas HIV viral load tests. These fully automated systems offer the fastest time to

results, highest throughput and longest walk-away time available among automated molecular platforms.

Roche also launched the Ventana HE 600 system globally. A fully automated hematoxylin and eosin tissue

staining system which enhances patient and technician safety and produces exceptional staining quality.

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Multiple tests on connected systems

The new Elecsys HTLV-I/II test enhances Roche’s blood screening portfolio in serology testing and

complements the most comprehensive diagnostics offering for blood safety solutions.

Accu-Chek Connect, a fully integrated diagnostic ecosystem with an app, an online portal, and an FDA-

approved bolus calculator to improve diabetes self-management, was launched in the US.

The FDA granted a Clinical Laboratory Improvement Amendments (CLIA) waiver for the cobas Strep A test

and the cobas Influenza A/B test for use on the cobas Liat system. These tests can now be used in non-

traditional diagnostic settings such as physicians’ offices, emergency rooms and other healthcare facilities to

provide results at the point of care.

In September 2015, Roche launched the cobas EGFR Mutation Test v2, its first oncology test that utilises

either plasma or tumour tissue samples. The test identifies over 40 mutations in the epidermal growth factor

receptor (EGFR) gene and can also be used as an aid in selecting and monitoring eligible patients with

NSCLC for therapy with an EGFR tyrosine kinase inhibitor medicine.

Roche Full Year Results 2015 – Event in London and live video webcast

The Roche Full Year Results 2015 event takes place in London today. Further details are available here. A live

video webcast will be available on http://ir.roche.com.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve

people’s lives.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology,

infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader

in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The

combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in

personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way

possible.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make

a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World

Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials

and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the

Pharmaceuticals, Biotechnology & Life Sciences Industry seven years in a row by the Dow Jones

http://www.roche.com/investors/agenda/annual-results-2015.htm

http://ir.roche.com/

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Sustainability Indices.

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed

more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of

CHF 48.1 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is

the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit

www.roche.com.

All trademarks used or mentioned in this release are protected by law.

Additional information

– Investor Update including a full set of tables: http://www.roche.com/inv-update-2016-01-28

– Full Year 2015 Presentation: http://www.roche.com/irp160128-a.pdf

– Full Year 2015 Presentation with appendix: http://www.roche.com/irp160128.pdf

– Pharmaceuticals: major clinical and regulatory news flow in 2015:

http://www.roche.com/pharmaAR15e.pdf

– Diagnostics: key diagnostics product launches in 2015: http://www.roche.com/diaAR15e.pdf

– Sustainable Development at Roche: http://www.roche.com/sustainability.htm

– Roche Annual Report 2015 (includes corporate responsibility report):

http://www.roche.com/annual_reports

– Dow Jones Sustainability Indices: http://www.sustainability-indices.com/

Roche Investor Relations

Dr. Karl Mahler Dr. Sabine Borngräber Phone: +41 61 68-78503 Phone: +41 61 68-88027 e-mail: [email protected] e-mail: [email protected] Dr. Bruno Eschli Dr. Tamer Farhan Phone: +41 61 68-75284 Phone: +41 61 68-82552 e-mail: [email protected] e-mail: [email protected] Dr. Birgit Masjost Phone: +41 61 68-84814 e-mail: [email protected]

Investor Relations North America

Nina Goworek Ekaterine Kortkhonjia Ph.D. Phone: +1 650 467 8737 Phone: +1 650 467 5873

www.roche.com

http://www.roche.com/inv-update-2016-01-28

http://www.roche.com/irp160128-a.pdf

http://www.roche.com/irp160128.pdf

http://www.roche.com/pharmaAR15e.pdf

http://www.roche.com/diaAR15e.pdf

http://www.roche.com/sustainability.htm

http://www.roche.com/annual_reports

http://www.sustainability-indices.com/

mailto:[email protected]




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e-mail: [email protected] e-mail: [email protected]

Disclaimer: Cautionary statement regarding forward-looking statements This document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, among others: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for 2015 or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche



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Appendix: Tables

1. Sales January to December 2015 and 2014 ........................................................................................................................................................................ 13 2. Quarterly sales and constant exchange rate sales growth by Division in 2015 and 2014 ............................................................................................ 14 3. Pharmaceuticals Division .................................................................................................................................................................................................... 15 4. Top 20 Pharmaceuticals Division product sales and constant exchange rate growth 2015 vs. 2014......................................................................... 16 5. Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth ...................................................... 17 6. Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth United States .............................. 18 7. Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth Europe ........................................ 19 8. Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth Japan ........................................... 20 9. Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth International* ............................ 21 10. Roche Group consolidated income statement for the twelve months ended 31 December 2015 .............................................................................. 22 11. Roche Group core results reconciliation – Full Year 2015.............................................................................................................................................. 23 12. Divisional core results reconciliation – Full Year 2015 ................................................................................................................................................... 24 13. Roche Group consolidated balance sheet .......................................................................................................................................................................... 25 14. Roche Group consolidated statement of cash flows ........................................................................................................................................................ 26

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1. Sales January to December 2015 and 2014

Twelve months ended % change

CHF millions 31 December

2015 2014 At CER In CHF

Pharmaceuticals Division 37,331 36,696 5 2

United States 17,616 15,822 6 11

Europe 8,734 9,422 4 -7

Japan 3,224 3,301 6 -2

International* 7,757 8,151 5 -5

Diagnostics Division 10,814 10,766 6 0

Roche Group 48,145 47,462 5 1

* Asia–Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, Others

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2. Quarterly sales and constant exchange rate sales growth by Division in 2015 and 2014

CHF millions

% change % change % change % change % change

Q4 2014 vs. Q1 2015 vs. Q2 2015 vs. Q3 2015 vs. Q4 2015 vs.

Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014

Pharmaceuticals Division 9,731 5 9,322 4 9,028 7 9,340 6 9,641 3

United States 4,294 10 4,392 6 4,194 7 4,461 7 4,569 3

Europe 2,352 4 2,178 1 2,113 3 2,185 6 2,258 5

Japan 895 5 763 -2 777 18 801 8 883 2

International* 2,190 0 1,989 9 1,944 5 1,893 4 1,931 2

Diagnostics Division 2,974 7 2,511 6 2,724 7 2,600 4 2,979 7

Roche Group 12,705 6 11,833 5 11,752 7 11,940 6 12,620 4

*Asia–Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, Others

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3. Pharmaceuticals Division

Top-selling pharmaceuticals and recent new launches

Total United States Europe Japan International*

January - December 2015 CHF m % CHF m % CHF m % CHF m % CHF m %


Avastin 6,684 9 3,058 8 1,813 4 746 14 1,067 15

Herceptin 6,538 10 2,384 15 2,010 1 260 5 1,884 16

Lucentis 1,520 -15 1,520 -15 - - - - - -

Perjeta 1,445 61 804 41 432 102 84 16 125 140


Xolair 1,277 25 1,277 25 - - - - - -

Tarceva 1,181 -7 638 -5 220 -18 92 1 231 -3

Activase/TNKase 935 20 890 21 - - - - 45 1

CellCept 785 0 201 -2 178 -8 56 7 350 4

Recent new launches

Kadcyla 769 51 308 4 323 104 58 82 80 118

Esbriet 563 ** 386 ** 152 378 - - 25 **

Zelboraf 214 -21 42 -41 125 -26 4 - 43 19

Erivedge 167 31 117 34 39 10 - - 11 106

Gazyva/Gazyvaro 128 164 76 69 21 327 - - 31 **

Alecensa 65 482 1 - - - 64 474 - -

Cotellic 2 - 1 - 1 - - - - - * Asia–Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, Others ** Over 500%

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4. Top 20 Pharmaceuticals Division product sales and constant exchange rate growth 2015 vs. 2014

CHF millions Total United States Europe Japan International*

CHF m % CHF m % CHF m % CHF m % CHF m %


Avastin 6,684 9 3,058 8 1,813 4 746 14 1,067 15

Herceptin 6,538 10 2,384 15 2,010 1 260 5 1,884 16

Lucentis 1,520 -15 1,520 -15 - - - - - -

Perjeta 1,445 61 804 41 432 102 84 16 125 140


Xolair 1,277 25 1,277 25 - - - - - -

Tarceva 1,181 -7 638 -5 220 -18 92 1 231 -3

Activase/TNKase 935 20 890 21 - - - - 45 1

CellCept 785 0 201 -2 178 -8 56 7 350 4

Kadcyla 769 51 308 4 323 104 58 82 80 118

Tamiflu 705 -28 533 -26 16 -76 65 -37 91 16

Pulmozyme 652 10 454 12 116 5 - - 82 11

Esbriet 563 ** 386 ** 152 378 - - 25 **

Pegasys 538 -44 85 -58 101 -52 15 -73 337 -33

Xeloda 513 -31 56 -71 42 -48 89 7 326 -17

Mircera 475 21 - - 87 -3 189 5 199 67

Valcyte/Cymevene 369 -45 89 -78 152 -7 - - 128 -10

NeoRecormon/Epogin 366 -11 - - 153 -9 47 -10 166 -13

Rocephin 279 2 - - 37 -7 29 -4 213 4 * Asia–Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, Others ** Over 500%

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5. Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth

CHF millions % change % change % change % change % change

Q4 2014 vs. Q1 2015 vs. Q2 2015 vs. Q3 2015 vs. Q4 2015 vs. Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014

MabThera/Rituxan 1,776 -1 1,744 5 1,752 6 1,772 4 1,777 4

Avastin 1,668 7 1,619 6 1,644 13 1,705 8 1,716 9

Herceptin 1,596 7 1,652 12 1,613 10 1,614 7 1,659 10

Lucentis 441 -5 394 -9 375 -16 373 -18 378 -17

Perjeta 285 103 322 82 337 64 376 57 410 50

Actemra/RoActemra 327 20 334 27 341 23 367 18 390 25

Xolair 274 29 281 28 312 27 339 21 345 22

Tarceva 321 -2 295 -3 307 -10 292 -7 287 -9

Activase/TNKase 188 5 221 15 216 16 239 14 259 36

CellCept 188 -4 197 -7 191 -1 194 -4 203 13

Kadcyla 165 110 179 80 183 54 196 44 211 36

Tamiflu 507 129 376 6 41 61 118 46 170 -67

Pulmozyme 170 4 146 4 160 15 166 14 180 8

Esbriet 44 - 88 - 141 - 157 - 177 296

Pegasys 204 -29 168 -39 117 -58 120 -45 133 -32

Xeloda 153 -56 136 -53 124 -29 124 -11 129 -9

Mircera 113 0 114 17 108 17 147 55 106 -1

Valcyte/Cymevene 181 -9 100 -41 87 -47 83 -52 99 -41

NeoRecormon/Epogin 118 -1 93 -10 89 -19 90 -8 94 -6

Rocephin 78 14 79 18 63 0 64 -8 73 -1

18/26

6. Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth United States



MabThera/Rituxan 851 5 937 10 938 7 947 4 938 7

Avastin 680 7 761 6 741 11 784 6 772 11

Herceptin 516 17 598 18 578 18 609 12 599 13

Lucentis 441 -5 394 -9 375 -16 373 -18 378 -17

Perjeta 160 86 187 60 192 43 208 37 217 31


Xolair 274 29 281 28 312 27 339 21 345 22

Tarceva 155 9 154 2 165 -15 159 -7 160 1

Activase/TNKase 176 4 210 16 206 18 228 15 246 36

CellCept 42 -18 43 -17 51 2 53 -14 54 29

Kadcyla 69 -7 78 -1 72 -2 79 6 79 12

Tamiflu 434 127 284 49 24 131 104 54 121 -74

Pulmozyme 105 9 102 4 109 15 115 9 128 19

Esbriet 5 - 50 - 98 - 114 - 124 *

Pegasys 27 -49 12 -82 13 -84 17 -45 43 74

Xeloda 14 -92 15 -89 16 -48 12 3 13 13

Mircera - - - - - - - - - -


NeoRecormon/Epogin - - - - - - - - - -

Rocephin -3 - - - - - - - - - * Over 500%

19/26

7. Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth Europe



MabThera/Rituxan 497 7 452 1 443 -1 455 1 468 3

Avastin 486 3 456 3 435 4 457 5 465 5

Herceptin 538 2 508 0 490 -1 502 0 510 4

Lucentis - - - - - - - - - -

Perjeta 81 171 89 140 99 125 114 96 130 74


Xolair - - - - - - - - - -

Tarceva 74 -9 58 -15 56 -16 54 -20 52 -23

Activase/TNKase - - - - - - - - - -

CellCept 52 -11 44 -10 43 -9 44 -10 47 -1

Kadcyla 65 * 73 229 79 135 83 92 88 49

Tamiflu 1 -93 11 -83 1 478 1 -65 3 455

Pulmozyme 30 -2 29 2 28 2 29 8 30 8

Esbriet 36 - 32 - 37 - 37 - 46 44

Pegasys 42 -46 31 -55 24 -58 24 -45 22 -45

Xeloda 16 -77 13 -59 9 -53 10 -41 10 -30

Mircera 25 -8 22 -3 22 -3 21 -1 22 -4


NeoRecormon/Epogin 44 -10 39 -10 38 -11 38 -9 38 -6

Rocephin 13 7 15 14 8 -8 5 -15 9 -27 * Over 500%

20/26

8. Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth Japan



MabThera/Rituxan 61 -4 52 1 55 28 59 7 64 9

Avastin 192 5 167 4 182 29 189 13 208 12

Herceptin 70 -7 60 -7 65 22 65 3 70 3

Lucentis - - - - - - - - - -

Perjeta 21 32 18 12 21 21 22 18 23 14


Xolair - - - - - - - - - -

Tarceva 26 -6 20 -12 23 8 25 12 24 -1

Activase/TNKase - - - - - - - - - -

CellCept 15 -13 12 -3 14 8 14 11 16 11

Kadcyla 14 - 12 - 15 81 15 39 16 23

Tamiflu 50 190 54 -2 -1 -97 - - 12 -75

Pulmozyme - - - - - - - - - -

Esbriet - - - - - - - - - -

Pegasys 11 -1 6 -50 5 -73 2 -82 2 -84

Xeloda 23 -8 20 -8 22 22 22 8 25 10

Mircera 51 -11 40 -14 47 23 48 6 54 9

Valcyte/Cymevene - - - - - - - - - -

NeoRecormon/Epogin 14 -39 11 -24 12 0 12 -7 12 -9

Rocephin 8 -15 7 -9 7 1 8 -2 7 -5

21/26

9. Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth International*



MabThera/Rituxan 367 -17 303 2 316 13 311 5 307 -2

Avastin 310 16 235 11 286 27 275 16 271 7

Herceptin 472 6 486 23 480 14 438 9 480 16

Lucentis - - - - - - - - - -

Perjeta 23 177 28 222 25 112 32 125 40 131


Xolair - - - - - - - - - -

Tarceva 66 -13 63 1 63 6 54 -1 51 -18

Activase/TNKase 12 12 11 -2 10 -10 11 -11 13 32

CellCept 79 13 98 -2 83 1 83 5 86 16

Kadcyla 17 ** 16 333 17 131 19 74 28 93

Tamiflu 22 350 27 -20 17 18 13 22 34 73

Pulmozyme 35 -1 15 9 23 34 22 49 22 -22

Esbriet 3 - 6 - 6 - 6 - 7 114

Pegasys 124 -17 119 -8 75 -42 77 -40 66 -42

Xeloda 100 -10 88 -17 77 -27 80 -11 81 -12

Mircera 37 30 52 99 39 24 78 206 30 -13

Valcyte/Cymevene 43 -1 36 4 34 -1 28 -17 30 -22

NeoRecormon/Epogin 60 28 43 -6 39 -29 40 -8 44 -5

Rocephin 60 30 57 25 48 2 51 -7 57 0 * Asia–Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, Others ** Over 500%

22/26

10. Roche Group consolidated income statement for the twelve months ended 31 December 2015

in millions of CHF Pharma-ceuticals

Diagnostics Corporate Group

Sales 37,331 10,814 - 48,145 Royalties and other operating income 2,119 139 - 2,258 Cost of sales (10,249) (5,211) - (15,460) Marketing and distribution (6,154) (2,660) - (8,814) Research and development (8,367) (1,214) - (9,581) General and administration (1,677) (579) (471) (2,727) Operating profit 13,003 1,289 (471) 13,821 Financing costs (1,574) Other financial income (expense) (260) Profit before taxes 11,987 Income taxes (2,931) Net income 9,056 Attributable to - Roche shareholders 8,863 - Non-controlling interests 193 Earnings per share and non-voting equity security Basic (CHF) 10.42 Diluted (CHF) 10.28

23/26

11. Roche Group core results reconciliation – Full Year 2015

in millions of CHF

IFRS

Glo

bal r

estr

uctu

ring

Inta

ngib

les

amor

tisat

ion

Inta

ngib

les

impa

irm

ent

Alli

ance

s & b

usin

ess

com

bina

tions

Lega

l &

envi

ronm

enta

l

Maj

or d

ebt

rest

ruct

urin

g

Pens

ion

plan

se

ttlem

ents

Nor

mal

isatio

n o

f EC

P ta

x be

nefit

Core

Sales 48,145 - - - - - - - - 48,145

Royalties and other operating income

2,258 - - - - - - - - 2,258

Cost of sales (15,460) 654 1,548 - 552 - - - - (12,706)

Marketing and distribution (8,814) 203 1 - - - - - - (8,610)

Research and development (9,581) 57 123 69 - - - - - (9,332)

General and administration (2,727) 148 - - 201 170 - (5) - (2,213)

Operating profit 13,821 1,062 1,672 69 753 170 - (5) - 17,542

Financing costs (1,574) 1 - - 40 12 381 - - (1,140)

Other financial income (expense) (260) - - - (16) - - - - (276)

Profit before taxes 11,987 1,063 1,672 69 777 182 381 (5) - 16,126

Income taxes (2,931) (195) (818) (20) (183) (40) (133) 1 30 (4,289)

Net income 9,056 868 854 49 594 142 248 (4) 30 11,837

Attributable to

- Rocheshareholders 8,863 863 845 47 594 141 248 (4) 29 11,626

- Non-controllinginterests 193 5 9 2 - 1 - - 1 211

EPS - diluted (CHF) 10.28 1.00 0.99 0.05 0.69 0.16 0.29 - 0.03 13.49

24/26

12. Divisional core results reconciliation – Full Year 2015

in millions of CHF

IFRS

Glo

bal

rest

ruct

urin

g

Inta

ngib

les

amor

tisat

ion

Inta

ngib

les

impa

irm

ent

Alli

ance

s & b

usin

ess

com

bina

tions

Lega

l &

envi

ronm

enta

l

Pens

ion

plan

se

ttle

men

ts

Cor

e

Pharmaceuticals Sales 37,331 - - - - - - 37,331Royalties and other operating income

2,119 - - - - - - 2,119

Cost of sales (10,249) 558 1,239 - 552 - - (7,900)Marketing and distribution

(6,154) 87 1 - - - - (6,066)

Research and development

(8,367) 46 118 69 - - - (8,134)

General and administration

(1,677) 65 - - 162 158 (3) (1,295)

Operating profit

13,003 756 1,358 69 714 158 (3) 16,055

Diagnostics Sales 10,814 - - - - - - 10,814Royalties and other operating income

139 - - - - - - 139

Cost of sales (5,211) 96 309 - - - - (4,806) Marketing and distribution

(2,660) 116 - - - - - (2,544)

Research and development

(1,214) 11 5 - - - - (1,198)

General and administration

(579) 77 - - 39 7 (2) (458)

Operating profit

1,289 300 314 - 39 7 (2) 1,947

Corporate General and administration

(471) 6 - - - 5 - (460)

Operating profit

(471) 6 - - - 5 - (460)

25/26

13. Roche Group consolidated balance sheet

in millions of CHF 31 December 2015

31 December 2014*

Non-current assets Property, plant and equipment 18,473 17,195 Goodwill 11,082 9,930 Intangible assets 13,861 12,799 Deferred tax assets 2,564 2,829 Defined benefit plan assets 642 691 Other non-current assets 959 982 Total non-current assets 47,581 44,426

Current assets Inventories 7,648 7,743 Accounts receivable 8,329 9,003 Current income tax assets 239 244 Other current assets 2,795 2,421 Marketable securities 5,440 7,961 Cash and cash equivalents 3,731 3,742 Total current assets 28,182 31,114

Total assets 75,763 75,540

Non-current liabilities Long-term debt (17,100) (19,347) Deferred tax liabilities (545) (504)Defined benefit plan liabilities (8,341) (8,994)Provisions (2,204) (1,778)Other non-current liabilities (505) (251)Total non-current liabilities (28,695) (30,874)

Current liabilities Short-term debt (6,151) (6,367) Current income tax liabilities (2,781) (2,616) Provisions (2,432) (2,465) Accounts payable (3,207) (2,883) Other current liabilities (9,197) (8,777) Total current liabilities (23,768) (23,108)

Total liabilities (52,463) (53,982)

Total net assets 23,300 21,558

Equity Capital and reserves attributable to Roche shareholders

20,979 19,586

Equity attributable to non-controlling interests 2,321 1,972 Total equity 23,300 21,558

* The balance sheet at 31 December 2014 has been restated following the finalisation of thevaluation of the net assets acquired related to the InterMune, Dutalys and Bina acquisitions in 2014.

26/26

14. Roche Group consolidated statement of cash flows

in millions of CHF 2015 2014

Cash flows from operating activities Cash generated from operations 20,651 20,305 (Increase) decrease in net working capital (431) (258)Payments made for defined benefit plans (538) (520)Utilisation of provisions (835) (873)Disposal of products 70 255 Other operating cash flows 30 3 Cash flows from operating activities, before income taxes paid 18,947 18,912 Income taxes paid (3,696) (2,982) Total cash flows from operating activities 15,251 15,930

Cash flows from investing activities Purchase of property, plant and equipment (3,468) (2,966) Purchase of intangible assets (642) (368)Disposal of property, plant and equipment 45 64 Disposal of intangible assets - - Business combinations (2,140) (9,633) Divestment of subsidiaries 6 - Interest and dividends received 28 35 Sales of marketable securities 55,660 68,426 Purchases of marketable securities (53,738) (67,887) Other investing cash flows (27) 325Total cash flows from investing activities (4,276) (12,004)

Cash flows from financing activities Proceeds from issue of bonds and notes 2,663 6,407 Redemption and repurchase of bonds and notes (4,058) (3,662) Increase (decrease) in commercial paper (791) 2,342Increase (decrease) in other debt 130 124 Hedging and collateral arrangements (400) (669)Changes in non-controlling interests (2) -Equity contribution by non-controlling interests - capital injection 40 - Interest paid (967) (976)Dividends paid (6,954) (6,718) Equity-settled equity compensation plans, net of transactions in own equity

(169) (812)

Other financing cash flows - - Total cash flows from financing activities (10,508) (3,964)

Net effect of currency translation on cash and cash equivalents (478) (220)Increase (decrease) in cash and cash equivalents (11) (258)

Cash and cash equivalents at beginning of period 3,742 4,000Cash and cash equivalents at end of period 3,731 3,742

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